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Director, Regulatory
2 months ago
Business Unit Overview:
Michael Foods, Inc. is a leader in the food processing and distribution industry with business in egg products, refrigerated grocery and potato products. We offer exciting job possibilities throughout our organization where you can enhance your career, sharpen your talents and make an impact. Join our company and be part of an innovative team that’s First in Food.
Location Description:Hopkins, MN is home to our Michael Foods, Inc. corporate headquarters. Hopkins is located 7 miles west of Minneapolis, boasting natural surroundings in a suburban environment that also provides quick access to major travel ways and local restaurants that give our community a distinct character. Located in the Excelsior Crossing building where employees are provided with beautifully landscaped walking paths and water features creating an optimal environment for outdoor and walking meetings, along with the opportunity to take a relaxing walk or outdoor lunch before, within, or after your work day.
Responsibilities:The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain. The position must effectively collaborate with all functional groups within the business, its customers, and external governmental agencies, primarily the FDA, USDA FSIS, USDA FAS, and USDA AMS. The position will work to identify opportunities to impact policy at a national and political level to enhance the value to the business and its customers.
In addition to providing leadership and oversite for regulatory compliance, this position has responsibility for overseeing the Food Safety and Quality Customer Care and Compliance department. This department is responsible for ensuring compliance with customer requirements and expectations, developing responses to customer concerns, and acting as the liaison between the customer and the manufacturing facilities.
The position will report to the VP of FSQ.
DUTIES AND RESPONSIBILITIES:
- Seek out and drive opportunities to add value to the business by impacting the development of regulatory policy, and governmental execution of policy, at a national and political level.
- Support the annual internal FSQ assessment process at all MFI facilities through verification of compliance to applicable food safety related regulatory requirements.
- Solicit, assess, draft, and submit value added project requests to the USDA FSIS New Technology group based on current and forthcoming regulations and/or process changes. Once approval is granted, monitor and submit data to the New Technology group in compliance with each specific waiver and letter of no objection that is obtained.
- Provide expertise and guidance regarding all customer and country required export documentation. This includes, but is not limited to, regulatory forms and letters, pro forma invoices, commercial invoices, packing lists, letters of credit, bank drafts, shippers export declaration/electronic export information, letters of instructions, Free Trade (NAFTA) Certificates, Certificates of Origin, Certificates of Analysis, “Food” Re-Export Certificates, USDA certificates, Proof of Delivery, and Bills of Lading.
- Solicit, draft, assess and submit comments to all applicable FDA and USDA proposed rules and guidance documents.
- Maintain all company and facility food safety related regulatory permits and approvals (e.g. - Grants of Inspection, Food Facility Registrations, Off-Premise Freezing Permits, Alternative Shipment Protocols, Forms 5200-6 for Export Certification, Voluntary Inspection, organizational chart updates, AMS Form LPS109, AMS PEEPEV approved products and plants lists, Voluntary PY200s for domestic shipments, etc.).
- Develop and maintain positive relationships with all internal functions and applicable regulatory agencies, while leading the management of any regulatory related issues that may arise at a plant or corporate level.
- Support the MFI manufacturing facilities through the interaction of regulatory bodies, where appropriate. Assist in developing written responses to non-conformances identified by USDA and FDA.
- Research regulations for a wide spectrum of applications, including, but not limited to, product development, ingredients use, animal disease, labeling, USDA challenges and appeals, and export compliance, for all MFI functions and facilities.
- Monitor various regulatory web sites (e.g. FSIS Export Library and FSMA), attend regulatory meetings and webinars, receive and review automatic notifications (e.g. FSIS, FDA, AMS, APHIS, OIE, Federal Registry), participate in industry groups and associations, and personally interact with regulatory officials to maintain an awareness of regulatory policy changes and an understanding of how it may affect the Integrated Supply Chain (ISC).
- Research countries’ import requirements, educating the sales force and the functions within supply chain on those requirements. Monitor existing countries’ continually changing requirements.
- Oversee the Customer Compliance department. Set goals and drive improvements which will support the team in ensuring compliance to customer expectations.
- Support the Customer Compliance team in the maintenance of customer required databases and information requests.
- Ensure that all customer complaints and concerns are appropriately investigated, and that appropriate responses are developed to support sales in effectively maintaining strong relationships with the MFI customer base.
- Ensure compliance with labeling requirements, claims (e.g. Kosher, Halal, Cage Free, etc) and state regulations (e.g. California Proposition 12, 65).
EDUCATION AND EXPEREINCE REQUIRED:
- Bachelor’s degree in business or a related field.
- A minimum of 10 years of experience in food related regulatory/compliance management is preferred.
- Experience working with federal and state agencies in food manufacturing organizations.
- Ability to work independently using sound judgment, legal research and organizational skills.
- Must have excellent interpersonal, verbal, written and presentation skills.
- Must be able to work with individuals at all levels of the organization.
- Must have proficiency with computer skills (such as Microsoft Office suite); experience developing and maintaining user databases for technical information and standardized forms is highly preferred.
- Must demonstrate adherence to ethical standards at all times.
- Knowledgeable and able acting in strict accordance with the requirements of all relevant laws, regulations, and Company policies, including, among other areas, Food and Drug Administration regulations.
- An extensive knowledge of food related regulations and the applicable regulatory bodies (e.g. – FDA and USDA).
- Self-motivated with the ability to prioritize and multi-task.
- Ability to lead and be a contributing member of cross functional teams.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Successful project management experience preferred.
- Business acumen, innovation, strategic thinking, professionalism, visionary leadership and problem-solving skills are beneficial.
